A flexible approach with an emphasis on the production of high-quality results, together with
a particular expertise in the rapid (real-time) turnaround of samples provides significant
advantages to our clients, for example in providing critical support for decision making in
dose-escalation studies. All assays are validated according to FDA guidelines and all reports
are produced to appropriate regulatory standards, either in the client’s own format or in the
default ICON standard.
In addition to providing support for ICON Development Solution’s in-house clinical pharmacology
activities, our Bioanalytical Services Unit also routinely provides support for phase I, II and
III studies conducted on other sites.
The unit has developed over 200 new drug assays, with 120 LC-MS/MS assays to standards set by
international regulatory authorities. It is UK MHRA GLP compliant, and offers analysis using
HPLC-UV/Fluorescence and LC-MS/MS.
In summary, the bioanalytical laboratory undertakes the following work:
Quantitative analysis of parent drugs and their metabolites in a variety of biological matrices
Develop/validate new assays
Implement/validate client’s own assay
Extend/validate an existing assay
Analysis of enantiomeric drugs components
Support in vitro drug metabolism and in vitro drug permeability studies
Support in vitro and in vivo drug interaction studies involving “cocktails” of CYP450 probes/substrates
Support pre-clinical animal studies
Support external phase I, II and III clinical trials
Cross validation of peptide assays from immuno-assay methods to LC-MS/MS
